Imaging Agent Dangers Being Monitored by FDA
The FDA has placed a cardiovascular imaging agent, known as regadenson (Lexiscan), on a quarterly list of products that are to be monitored. The agent has appeared on this list due to potential symptoms of the condition myocardial infarction, or MI, and even death.
About the Imaging Agent
Regadenoson is an adenosine-receptor agonist. It produces vasodilation in coronary arteries and is used for radionuclide myocardial perfusion imaging in individuals who do not have the ability to endure, for medical or other reasons, exercise stress testing. The agent is also used for CT imaging.
According to MedScape, the FDA received reports possibly linking Regadenoson was approved by the FDA in 2008 and included warning of a risk for MI and ventricular arrhythmias. In 2011 the drug made the list for signals of QT, and during the second quarter of 2013, the FDA began receiving reports through the FDA Adverse Event Reporting System of cases of MI and death.
Adverse Events Tied to the Imaging Agent
Infomration provided by DrugCite.com
- Loss of consciousness
- Unresponsiveness to stimuli
- Cardiac Arrest
FDA and Watch Listing
Though a drug or product is placed on the FDA watch list, the agency has not conclusively determined whether or not the drug or product poses the reported risks. Instead, the agency further investigates the need to confirm the relationship between the symptoms and the drug or product. The FDA also highlights that a drug or product being on the watch list is not reason for a medical professional to cease using or prescribing.
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